MAUDE Adverse Event Report: ALARIS (CAREFUSION) CONTROLLER

Model Number 8015

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988)

Event Date 03/23/2015

Event Type  Injury  

Event Description

At 1011, new syringe of mso4 was placed in pca pump.Pca pump programmed according to md orders.Morphine 30mg/30ml (1mg/1ml) pca, loading dose: 3mg, demand dose: 0.5mg, basal rate: 035 mg/hr, lookout interval: 15 min, 1 hr dose limit: 8 mg, clinician bolus: 1mg q 15 min prn pain.Pain.Programming checked by 2 rns and a student nurse.Approximately 4 hours later, pca pump alarming with message that syringe empty.Patient was arousable with effort.Vital signs taken: temp - 97.8, pulse - 55, bp - 88/55, resp - 16, room air, 02 sats - 96 percent.Md notified, patient given 0.2 mg narcan and became alert and awake.Morphine pca discontinued per md.Iv pump and pca module sent to biomed.Event log report performed on pca pump by biomed.In contact with carefusion/alaris customer advocacy to interpret event log report.Unknown actual cause of patient event at this time.Working with carefusion/alaris advocate to determine next steps.Iv pca pump and tubing sequestered in biomed per protocol.Diagnosis or reason for use: patient controlled analgesic.Event abated after use stopped or dose reduced: yes.

• Brand Name: CONTROLLER
• Type of Device: CONTROLLER
• Manufacturer (Section D): ALARIS (CAREFUSION); san diego CA 92121
• MDR Report Key: 4684328
• MDR Text Key: 5676078
• Report Number: MW5042059
• Device Sequence Number: 2
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: START 03/22/2015, STOP - 03/23/2015.; CLINICIAN BOLUS - 1 MG Q 15 MIN PRN PAIN.; ALARIS (CAREFUSION) CONTROLLER; PCA SYRINGE: LEADING DOSE: - 3 MG,; START: 3/22/2015, STOP - 03/23/2015.; INFUSION PUMP (BRAIN); ALARIS (CAREFUSION) MODULE, PCA PUMP; LOCKOUT INTERVAL - 15 MIN, 1 HR DOSE LIMIT - 8 MG; MORPHINE 30 MG/ 30 ML (1 MG/1 ML); DEMAND DOSE - 0.5 MG, BASAL RATE - 0.5 MG/HR
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 47